Unani Pharmacopoeia Committee

The Unani System of Medicines originated in Greece and was developed by Arabs into an elaborate medical science based on the frame work of the teachings of Buqrat (Hippocrates) and Jalinus (Galen). Since then it has been known as Greco-Arab Medicine. This system also got enriched by imbibing what was the best in the contemporary systems of traditional medicine in Egypt, Syria, Iraq, Persia, India, China and other Middle and Far Eastern Countries. It also benefited from the native medical systems in vogue at the time in various parts of Central Asia. In India, Unani system of Medicine was introduced by the Arabs and soon it took firm roots in Indian soil and has ever since been serving vast sections of its people. It may be added that the Unani System, wherever it went, absorbed what was best in the native system in vogue, thereby adding to its vast repertory. This process of enrichment continues even today. The Unani physicians who settled in India were not content with borrowing known Indian drugs only. They subjected new drugs to clinical tests and as a result of their experimentation added numerous new drugs to their own system. It was because of its vast wealth of knowledge and experience that the system found immediate favor with the masses and soon spread all over the country and continued to hold unchallenged sway for centuries.

As already stated, the foundation of Unani System was laid by Buqrat (460 B.C.). He was the first to establish that disease was a natural process, that its symptoms were the reactions of the body to the disease and that the chief function of the physician was to aid the natural forces of the body. He freed medicine from superstition on the one hand, and from wild philosophic speculation on the other, and intelligently directed it towards its immediate and only goal – the cure of the patient. He was the first to lay the foundation of therapeutics on careful observation and experiment. He was also the first physicians and the only one on record from antiquity to introduce the method of taking medical histories. The well-known humoral theory is also one of his chief contributions to the medical realm.

Some of the other luminaries of Unani Medicine are Avenzoar (1072-1162 A.D.1), (Razi) (850-932 A.D.2), Ibn Sina (Avicenna) (980-1037 A.D.3), Ibn-e-Nafis (1210-1288 A.D.), Ibn-e-Betar (1197-1248 A.D.), and Hunain (809-873 A.D.) whose work ‘Ten Treatises on the Eye’ is the very earliest systematic text book on Ophthalmology. Avenzoar linked surgery, therapeutics and pharmacology into a homogeneous whole. In his treatise on ‘Small pox and Measles’ Rhazes gave a clear account of these two diseases for the first time. He was also the first physician, in the entire medical history, to introduce mercury ointment. His compilation ‘Al-Hawi’, a work on clinics, is also praiseworthy and is still preserved. It runs in 25 volumes and deals with all aspects of disease. Avicenna’s Al-Qanoon’ (Canon of Medicine), has been the most famous book in the medical world. In fact it was an encyclopaedia of the medical knowledge of his day. It was the medical Bible for several Asian and European civilizations for more than six centuries. Kitabul Hashaish and Dioscoredes contains information on single drugs used in Unani system of Medicine since time immemorial.

Since remote past it has been the practices that the knowledge of identifying the drugs and manufacturing of the compound preparations was confined to the practicing physicians alone. This was later on transferred from one generation to another by way of teacher-to-taught training system which resulted in the restriction of the system to a particular class of society. The physicians changed the formulations and used the drugs of their own choice according to the parameters suited to them. After a lapse of long period and break of continuity over the ages, the classical formulations got altered or aberrated, variation in composition became an established practice, preparations were named after the physicians and the same formulation got mingled with different compositions resulting in different therapeutic action of uncertainty. Similarly the original single drugs were either substituted or adulterated by way of wrong collection, identifications, naming, etc. by untrained and unskilled hands. The drug yielding plants or parts thereof occurring in a particular formula have been attributed with a number of medicinal virtues and hence usage. The translations of the classical texts were also wrongly interpreted. All these factors have contributed to a state of confusion and uncertainty about compound formulations, identity and use of the drugs, etc.

Due to commercialization in every sphere of life, the old methods of manufacturing the drugs, have now been taken over by the modern technological methods of the pharmaceutical industries, excepting in few cases of small scale preparations, particularly in rural areas, where the physician still identifies his drugs and makes the preparation according to his requirement. On account of increasing urbanization, the tendency is towards more and more dependence on readymade preparations. The physician prescribes and the patient purchases from the manufacturer or retailer directly. The increasing needs of the population and the chronic shortage of authentic raw materials demand that some sort of uniformity in the manufacture of Unani medicines should be brought about. The need has also been felt for statutory control to ensure standards for Unani drugs. Evolution of standards for Unani drugs, in the modern sense, considering the vast number of such drugs and their formulations, is a time and money-consuming task, and will take considerable time for its achievement.

In a view of the present trend of commercialization in the preparation and marketing of Unani medicines and to ensure the interest of the profession and public, the Government of India considered it expedient to utilize the existing law which controls the manufacture for sale of allopathic drugs, namely the Drugs and Cosmetics Act, 1940, to also control, in a limited measure, the Unani, Ayurvedic and Siddha drugs by amending the Act.

The Act was accordingly amended in 1964, to ensure a limited control over the production and sale of these medicines, namely:-

1. the manufacture should be carried under prescribed hygienic conditions, under the supervision of a person having prescribed qualifications;
2. the raw materials used in the preparation of drugs should be genuine and properly identified, and
3. the formula or the true list of all the ingredients contained in the drugs, should be displayed on the label of every container.

Development of standards for the identity, quality and purity of single drugs, to start with, and of formulations, at a later stage, assume importance for the effective enforcement of the provisions of the Drugs and Cosmetics Act. If the raw materials to be used in a medicine, and the stage by stage processes of manufacture, are standardized, the final product, namely the compound formulation can be expected to conform to uniform standards. The requirement that the list of ingredients be displayed on the label will enable analysts to verify label claims and to that extent will bind the manufacturer. Arrangements to evolve and lay down physical, chemical and biological tests, wherever necessary, to identify the drugs and ascertain its quality, and to detect adulterants are an urgent necessity. Setting up of Drug Standardization, Testing and Control Laboratories for Unani Medicines, both at All India and regional levels for this purpose is, therefore, essential. The several committees appointed by the Government of India to assess and evaluate the status and practice of Unani Medicine have stressed the importance of preparing an official Unani Pharmacopoeia.

MINISTRY OF AYUSH

NOTIFICATION

New Delhi, 8^th July, 2022

(Constitution of Unani Sub-Committees under Pharmacopoeia Committee (PC) of PCIM&H)

G.S.R. 526(E)- in continuation of Gazette Notification CG-DL-E-23032021-226036, Part-II, Section-3, Sub-Section (i) (Extra Ordinary) dated 23^rd March, 2021 and in exercise of the powers conferred by Rule 163-AA (1) of Drugs and Cosmetics Rules, 1945, the Central Government, hereby constitutes Pharmacopoeia Committee (PC) and various Sub-Committee thereunder, under the Scientific Advisory Board (SAB) of Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H), Ghaziabad as follows:

(F.No. Y.11015/05/2022-1.P)

Kavita Garg, Jt. Secy.